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Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santen Inc.
ClinicalTrials.gov Identifier:
NCT00650338
First received: March 27, 2008
Last updated: November 1, 2011
Last verified: November 2011

March 27, 2008
November 1, 2011
March 2008
September 2008   (final data collection date for primary outcome measure)
To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00650338 on ClinicalTrials.gov Archive Site
To compare the safety and efficacy of DE-104 ophthalmic solution with placebo and 0.005% latanoprost. [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension
A Randomized, Double-masked, Placebo- and Active- Controlled, Parallel-group, Multi-center, Dose-response Trial of DE-104 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

To investigate the dose-response relationship of DE-104 ophthalmic solution in lowering intraocular pressure (IOP) in subjects with Primary Open-Angle Glaucoma or Ocular Hypertension

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Open-Angle Glaucoma
  • Ocular Hypertension
  • Drug: DE-104 ophthalmic solution, low concentration
    Topical ocular application
  • Drug: DE-104 ophthalmic solution, medium concentration
    Topical ocular application
  • Drug: DE-104 ophthalmic solution, high concentration
    Topical ocular application
  • Drug: Placebo
    placebo
  • Drug: 0.005% latanoprost
    Topical ocular application
  • Experimental: 1
    <described in intervention>
    Intervention: Drug: DE-104 ophthalmic solution, low concentration
  • Experimental: 2
    <described in intervention>
    Intervention: Drug: DE-104 ophthalmic solution, medium concentration
  • Experimental: 3
    <described in intervention>
    Intervention: Drug: DE-104 ophthalmic solution, high concentration
  • Placebo Comparator: 4
    <described in intervention>
    Intervention: Drug: Placebo
  • Active Comparator: 5
    <described intervention>
    Intervention: Drug: 0.005% latanoprost
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
165
October 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Provided signed, written informed consent.
  • Diagnosed with primary open-angle glaucoma or ocular hypertension.
  • 18 years of age and older.
  • If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.

Exclusion Criteria:

  • Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
  • Presence of any abnormality or significant illness that could be expected to interfere with the study.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00650338
27-002
Not Provided
Santen Inc.
Santen Inc.
Not Provided
Not Provided
Santen Inc.
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP